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FDA 510(k), K163537, Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
FDA 510(k), K163537, Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
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$89.00 USD
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510(K) Number: K163537
Device Name: Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
Manufacturer: Covidien llc
Device Classification Name: bronchoscope (flexible or rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 12/16/2016
Decision Date: 04/21/2017
Regulation Medical Specialty: Ear Nose & Throat
Device Name: Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
Manufacturer: Covidien llc
Device Classification Name: bronchoscope (flexible or rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 12/16/2016
Decision Date: 04/21/2017
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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